Manufacturer's investigation conclusion: the reported event of the 14v li-ion battery not being accepted for charge was able to be confirmed.The 14v li-ion battery (serial number: (b)(4) was returned for analysis and tested.The battery was connected to a mock loop and was able to operate a pump; however, when placed in the universal battery charger (ubc), the battery was not accepted for charge due to an issue with the smbus.The battery was cut open to perform circuit analysis.The voltages along the smbus lines were measured and pin 2 on the diode d21 was found to be shorted to ground.Pin 2 is associated with smb_c.No further testing was conducted.The root cause of the reported event was unable to be conclusively determined through this investigation.The device history records for the 14v li-ion battery were unable to be reviewed due to the records being maintained by the vendor and are unavailable.Heartmate 3 patient handbook under section 5 ¿alarms and troubleshooting¿ and heartmate 3 instructions for use (ifu) under section 7 ¿alarms and troubleshooting¿, explain all battery charger alarms, and the actions to take when a battery charger alarm occurs.Heartmate 3 patient handbook section 6 "caring for the equipment" and heartmate 3 ifu section 8 "equipment storage and care" describe how to care for, maintain, and store the 14v batteries.Heartmate 3 patient handbook section 10 and heartmate 3 ifu section f, both entitled ¿safety checklists¿, provide checklists to assist the patient in performing routine maintenance of heartmate 3 left ventricular assist device (lvad).Heartmate 3 patient handbook and heartmate 3 ifu section 3 ¿powering the system¿ explain the various ways to power the heartmate iii lvas, including how to use the 14v batteries.This section informs the user of how to charge the 14v batteries using the universal battery charger.The patient handbook cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.
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